Significant Accounting Policies (Policies) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Nature of Operations [Policy Text Block] |
Navidea ’s Manocept platform is predicated on the ability to specifically target the
CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Lymphoseek® (technetium Tc99m tilmanocept) injection, the first product developed and commercialized by Navidea based on the platform. Building on the success of Tc99m tilmanocept, the flexible and versatile Manocept platform acts as an engine for the design of purpose-built molecules offering the potential to be utilized across a range of diagnostic modalities, including single photon emission computed tomography (“SPECT”), positron emission tomography (“PET”), intra-operative and/or optical-fluorescence detection in a variety of disease states.On March 3, 2017, pursuant to an Asset Purchase Agreement dated November 23, 2016, ( the “Purchase Agreement”), the Company completed its previously announced sale to Cardinal Health 414, LLC (“Cardinal Health 414” ) of its assets used, held for use, or intended to be used in operating its business of developing, manufacturing and commercializing a product used for lymphatic mapping, lymph node biopsy, and the diagnosis of metastatic spread to lymph nodes for staging of cancer (the “Business”), including the Company’s radioactive diagnostic agent marketed under the Lymphoseek
® trademark for current approved indications by the U.S. Food and Drug Administration (“FDA”) and similar indications approved by the FDA in the future (the “Product”), in Canada, Mexico and the United States (the “Territory”) (giving effect to the License-Back described below and excluding certain assets specifically retained by the Company) (the “Asset Sale”). Such assets sold in the Asset Sale consist primarily of, without limitation, (i) intellectual property used in or reasonably necessary for the conduct of the Business, (ii) inventory of, and customer, distribution, and product manufacturing agreements related to, the Business, (iii) all product registrations related to the Product, including the new drug application approved by the FDA for the Product and all regulatory submissions in the United States that have been made with respect to the Product and all Health Canada regulatory submissions and, in each case, all files and records related thereto, (iv) all related clinical trials and clinical trial authorizations and all files and records related thereto, and (v) all rights, title and interest in and to the Product, as specified in the Purchase Agreement (the “Acquired Assets”).Upon closing of the Asset Sale, the Supply and Distribution Agreement, dated November 15, 2007 ( as amended, the “Supply and Distribution Agreement”), between Cardinal Health 414 and the Company was terminated and, as a result, the provisions thereof are of no further force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination).The Asset Sale to Cardinal Health 414 in March 2017 significantly improved our financial condition and our ability to continue as a going concern. The Company also continues working to establish new sources of non-dilutive funding, including collaborations and grant funding that can augment the balance sheet as the Company works to reduce spending to levels that can be supported by our revenues.Our consolidated balance sheets and statements of operations have been reclassified, as required, for all periods presented to reflect the Business as a discontinued operation. Cash flows associated with the operation of the Business have been combined with operating, investing and financing cash flows, as appropriate, in our consolidated statements of cash flows. Other than Tc99m tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, none of the Company’s drug product candidates have been approved for sale in any market.In January 2015, Macrophage Therapeutics, Inc. (“MT”), a majority-owned subsidiary, was formed specifically to explore immuno-therapeutic applications for the Manocept platform.From our inception through August 2011, we also manufactured a line of gamma detection systems called the neoprobe® GDS system (the “GDS Business”). We sold the GDS Business to Devicor Medical Products, Inc. (“Devicor”) in
August 2011. In exchange for the assets of the GDS Business, Devicor made net cash payments to us totaling $30.3 million, assumed certain liabilities of the Company associated with the GDS Business, and agreed to make royalty payments to us of up to an aggregate maximum amount of $20 million based on the net revenue attributable to the GDS Business through 2017. We recorded income of $759,000, net of taxes, in 2015 related to royalty amounts earned based on 2015 GDS Business revenue. The royalty amount of $1.2 million was offset by $436,000 in estimated taxes which were allocated to discontinued operations, but were fully offset by the tax benefit from our net operating loss for 2015. We did not earn or receive any such royalty payments prior to 2015 or in 2016.
In December 2001, we acquired Cardiosonix Ltd. (“Cardiosonix”), an Israeli company with a blood flow measurement device product line in the early stages of commercialization. In August 2009, the Company’s Board of Directors decided to discontinue the operations and attempt to sell Cardiosonix. However, we were obligated to continue to service and support the Cardiosonix devices through
2013. The Company has not received significant expressions of interest in the Cardiosonix business and as such, we continue to wind down our activities in this area until a final shutdown of operations is completed.In
July 2011, we established a European business unit, Navidea Biopharmaceuticals Limited, to address international development and commercialization needs for our technologies, including Tc99m tilmanocept. Navidea owns 100% of the outstanding shares of Navidea Biopharmaceuticals Limited. |
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Consolidation, Policy [Policy Text Block] |
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Use of Estimates, Policy [Policy Text Block] |
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Fair Value of Financial Instruments, Policy [Policy Text Block] |
Level
1
– Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level
2
– Quoted prices in markets that are
not active or financial instruments for which all significant inputs are observable, either directly or indirectly; andLevel
3
– Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
A financial instrument ’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In determining the appropriate levels, we perform a detailed analysis of the assets and liabilities whose fair value is measured on a recurring basis. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or
no price transparency are classified as Level 3. See Note 4.
The following methods and assumptions were used to estimate the fair value of each class of financial instruments:
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Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] |
Stock options granted under the 2002 Plan and the 2014 Plan generally vest on an annual basis over one to four years. Outstanding stock options under the plans, if not exercised, generally expire ten years from their date of grant or up to 90 days following the date of an optionee’s separation from employment with the Company. We issue new shares of our common stock upon exercise of stock options.
In September 2016, the Board of Directors approved the 2016 Stock Incentive Plan (the “2016 Plan”), authorizing a total of 10 million shares. The 2016 Plan has not yet been approved by Navidea’s stockholders. In connection with Dr. Goldberg’s appointment as Chief Executive Officer of the Company in
September 2016, the Board of Directors awarded options to purchase 5,000,000 shares of our common stock to Dr. Goldberg, subject to stockholder approval of the 2016 Plan. If approved, these stock options will vest 100% when the average closing price of the Company’s common stock over a period of five consecutive trading days equals or exceeds $2.50 per share, and expire on the tenth anniversary of the date of grant.Stock-based payments to employees and directors, including grants of stock options, are recognized in the consolidated statement of operations based on their estimated fair values. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Expected volatilities are based on the Company ’s historical volatility, which management believes represents the most accurate basis for estimating expected future volatility under the current circumstances. Navidea uses historical data to estimate forfeiture rates. The expected term of stock options granted is based on the vesting period and the contractual life of the options. The risk-free rate is based on the U.S. Treasury yield in effect at the time of the grant. The assumptions used to calculate the fair value of stock option awards granted during the years ended
December 31, 2016,
2015 and 2014 are noted in the following table:
The portion of the fair value of stock-based awards that is ultimately expected to vest is recognized as compensation expense over either (
1 ) the requisite service period or (2 ) the estimated performance period. Restricted stock awards are valued based on the closing stock price on the date of grant and amortized ratably over the estimated life of the award. Restricted stock may vest based on the passage of time, or upon occurrence of a specific event or achievement of goals as defined in the grant agreements. In such cases, we record compensation expense related to grants of restricted stock based on management’s estimates of the probable dates of the vesting events. Stock-based awards that do
not vest because the requisite service period is not met prior to termination result in reversal of previously recognized compensation cost. See Note 5.
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Cash and Cash Equivalents, Policy [Policy Text Block] |
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Receivables, Policy [Policy Text Block] |
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Inventory, Policy [Policy Text Block] |
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Property, Plant and Equipment, Policy [Policy Text Block] |
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Intangible Assets, Finite-Lived, Policy [Policy Text Block] |
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Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] |
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Lessee, Leases [Policy Text Block] |
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Derivatives, Policy [Policy Text Block] |
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Revenue Recognition, Policy [Policy Text Block] |
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Research and Development Expense, Policy [Policy Text Block] |
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Income Tax, Policy [Policy Text Block] |
Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result,
no liability for uncertain tax positions was recorded as of December 31,
201
6 or 2015 and we do not expect any significant changes in the next twelve months. Should we need to accrue interest or penalties on uncertain tax positions, we would recognize the interest as interest expense and the penalties as a selling, general and administrative expense. As of December 31, 2016, tax years 2013 -2016 remained subject to examination by federal and state tax authorities. See Note 18.
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New Accounting Pronouncements, Policy [Policy Text Block] |
In November 2015, the FASB issued ASU No. 2015 -17, Balance Sheet Classification of Deferred Taxes . ASU 2015 -17 eliminates the requirement to bifurcate deferred taxes between current and noncurrent on the balance sheet and requires that deferred tax assets and liabilities be classified as noncurrent on the balance sheet. ASU 2015 -17 may be applied retrospectively or prospectively and early adoption is permitted. We early-adopted ASU 2015 -17 as of December 31, 2015 and the statement of financial position as of this date reflects the revised classification of current deferred tax assets and liabilities as noncurrent. Adoption of ASU 2015 -17 resulted in a retrospective reclassification between current deferred tax assets and noncurrent deferred tax assets.As a result of the Asset Sale, our consolidated balance sheets and statements of operations have been reclassified, for all periods presented to reflect the Business as a discontinued operation, including interest expense related to the CRG and Platinum notes, as required by Accounting Standards Codification
205 -20 -45 -6.
In February 2016, the FASB issued ASU No. 2016 -02, Leases (Topic 842 ). ASU
2016 -02 requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016 -02 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. We expect the adoption of ASU 2016 -02 to result in an increase in right-of-use assets and lease liabilities on our consolidated statement of financial position related to our leases that are currently classified as operating leases, primarily for office space. Management is currently evaluating the impact that the adoption of ASU 2016 -02 will have on our consolidated financial statements.In March 2016, the FASB issued ASU
No. 2016 -08, Revenue from Contracts with Customers – Principal versus Agent Considerations (Reporting Revenue Gross versus Net)
. ASU
2016 -08 does not change the core principle of the guidance, rather it clarifies the implementation guidance on principal versus agent considerations. ASU 2016 -08 clarifies the guidance in ASU No. 2014 -09, Revenue from Contracts with Customers (Topic , which is 606 )not yet effective. The effective date and transition requirements for ASU 2016 -08 are the same as for ASU 2014 -09, which was deferred by one year by ASU No. 2015 -14, Revenue from Contracts with Customers – Deferral of the Effective Date
. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after
December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2014 -09 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In March 2016, the FASB issued ASU No. 2016 -09, Compensation – Stock Compensation . ASU
2016 -09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Some of the simplified areas apply only to nonpublic entities. ASU 2016 -09 is effective for public business entities for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016 -09 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. Methods of adoption vary according to each of the amendment provisions. Management is currently evaluating the impact that the adoption of ASU 2016 -09 will have on our consolidated financial statements.In April 2016, the FASB issued ASU No. 2016 -10, Revenue from Contracts with Customers – Identifying Performance Obligations and Licensing . ASU
2016 -10 does not change the core principle of the guidance, rather it clarifies the identification of performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. ASU 2016 -10 clarifies the guidance in ASU No. 2014 -09, Revenue from Contracts with Customers (Topic , which is 606 )not yet effective. The effective date and transition requirements for ASU 2016 -10 are the same as for ASU 2014 -09, which was deferred by one year by ASU No. 2015 -14, Revenue from Contracts with Customers – Deferral of the Effective Date
. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after
December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016 -120 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In May 2016, the FASB issued ASU No. 2016 -12, Revenue from Contracts with Customers – Narrow-Scope Improvements and Practical Expedients . ASU
2016 -12 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. ASU 2016 -12 affects the guidance in ASU No. 2014 -09, Revenue from Contracts with Customers (Topic , which is 606 )not yet effective. The effective date and transition requirements for ASU 2016 -12 are the same as for ASU 2014 -09, which was deferred by one year by ASU No. 2015 -14, Revenue from Contracts with Customers – Deferral of the Effective Date
. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after
December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016 -12 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In August 2016, the FASB issued ASU No. 2016 -15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments . ASU
2016 -15 addresses certain specific cash flow issues with the objective of reducing the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement cash flows. ASU 2016 -15 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted in any interim or annual period. If an entity early adopts ASU 2016 -15 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. ASU 2016 -15 should be applied using a retrospective transition method to each period presented, with certain exceptions. We adopted ASU 2016 -15 upon issuance, which resulted in debt prepayment costs being classified as financing costs rather than operating costs on the statement of cash flows for the year ended December 31, 2016.
In November 2016, the FASB issued ASU No. 2016 -18, Statement of Cash Flows – Restricted Cash . ASU
2016 -18 requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and restricted cash or equivalents. Therefore, restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016 -18 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption in permitted, including adoption in an interim period. If an entity early adopts ASU 2016 -18 in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes the interim period. Following the payoff of our CRG debt and release of our restricted cash in March 2017, we do not expect the adoption of ASU 2016 -18 to have a material effect on our consolidated financial statements.In December 2016, the FASB issued ASU No. 2016 -20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. ASU
2016 -20 does not change the core principle of the guidance, rather it affects only certain narrow aspects of Topic 606, including loan guarantee fees, contract cost impairment testing, provisions for losses on construction- and production-type contracts, clarification of the scope of Topic 606, disclosure of remaining and prior-period performance obligations, contract modification, contract asset presentation, refund liability, advertising costs, fixed-odds wagering contracts in the casino industry, and cost capitalization for advisors to private and public funds. ASU 2016 -20 affects the guidance in ASU No. 2014 -09, Revenue from Contracts with Customers (Topic , which is 606 )not yet effective. The effective date and transition requirements for ASU 2016 -12 are the same as for ASU 2014 -09, which was deferred by one year by ASU No. 2015 -14, Revenue from Contracts with Customers – Deferral of the Effective Date
. Public business entities should adopt the new revenue recognition standard for annual reporting periods beginning after
December 15, 2017, including interim periods within that year. Early adoption is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that year. We will evaluate the potential impact that the adoption of ASU 2016 -20 may have on our consolidated financial statements following the closing of the Asset Sale to Cardinal Health 414 in March 2017.
In
January 2017, the FASB issued ASU No. 2017 -01, Business Combinations (Topic 805 ), Clarifying the Definition of a Business. ASU
2017 -01 provides a screen to determine when a set of assets and activities (collectively, a “set”) is not a business. The screen requires that when substantially all of the fair market value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. If the screen is not met, ASU 2017 -01 (1 ) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output, and (2 ) removes the evaluation of whether a market participant could replace missing elements. ASU 2017 -01 is effective for public business entities for annual periods beginning after December 15, 2017, including interim periods within those periods. ASU 2017 -01 should be applied prospectively on or after the effective date. No disclosures are required at transition. Early adoption is permitted for certain transactions as described in ASU 2017 -01. Management is currently evaluating the impact that the adoption of ASU 2017 -01 will have on our consolidated financial statements. |